Regulatory Affairs Strategist

4 days ago

Sydney, New South Wales, Australia Careerlink People Solutions Full time

Careerlink People Solutions is partnering with BiomeBank to present a unique opportunity for an experienced professional in regulatory affairs to join the team as Regulatory Affairs Strategist.

BiomeBank, a clinical stage biotechnology company, aims to treat and prevent disease by restoring gut microbial ecology. With a mission-driven approach, they have achieved the first regulatory approval for a donor-derived microbiome drug product worldwide.

The Role

This role reports directly to the Chief Operations Officer and is responsible for developing and implementing global (FDA, TGA, EMA) regulatory strategy, filings, and product development requirements to ensure successful product registration and life-cycle management of unique microbial therapeutics serving patients with unmet medical needs.

Your key responsibilities will include:

  • Developing a clear regulatory strategy to lead all regulatory submissions worldwide
  • Leading a cross-functional team to ensure successful regulatory strategy, drafting, and submission
  • Management of project timelines and budgets, ensuring high-quality delivery to meet company goals
  • Regular reviews of the regulatory landscape regarding live bacterial therapeutics (cultured and donor-derived) for FDA, TGA, EMA as new guidance develops and publishes

To succeed in this role, you will bring:

  • A degree in biotechnology, biology, microbiology, or a related field
  • Experience working with cell therapies
  • Advanced training in regulatory affairs
  • Experience providing strategic regulatory advice in US, AU, EU jurisdictions through all stages of development, including pre-approval and marketed products
  • Experience leading major FDA submissions and FDA meetings
  • A proven track record of successful interactions with FDA/TGA/EMA and sound judgment in risk assessment
  • Highly conversant knowledge of emerging regulations and guidance, including GMPs and GCPs, with the ability to obtain key answers when issues aren't directly addressed
  • Demonstrated leadership skills with the ability to manage high volumes of work and competing priorities

This role offers a chance to take on a pivotal position in the growth and development of the BiomeBank team and contribute to the expansion of their innovative services.

We are seeking a dynamic and results-driven individual who can excel in this challenging role and thrive in a close-knit, passionate, and innovative team at the forefront of microbiome research.

Estimated Salary: $120,000 - $180,000 per annum, depending on experience.

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